Federal Practitioner

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

A version of this article first appeared on Medscape.com.

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

A version of this article first appeared on Medscape.com.

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

A version of this article first appeared on Medscape.com.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

WASHINGTON – Dysregulated stress systems may help explain why childhood trauma has such a dramatic and enduring psychiatric impact, new research suggests.

“We already knew childhood trauma is associated with the later development of depressive and anxiety disorders, but it’s been unclear what makes sufferers of early trauma more likely to develop these psychiatric conditions,” study investigator Erika Kuzminskaite, PhD candidate, department of psychiatry, Amsterdam University Medical Center (UMC), the Netherlands, told this news organization.
 

“The evidence now points to unbalanced stress systems as a possible cause of this vulnerability, and now the most important question is, how we can develop preventive interventions,” she added.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Elevated cortisol, inflammation

The study included 2,779 adults from the Netherlands Study of Depression and Anxiety (NESDA). Two thirds of participants were female.

Participants retrospectively reported childhood trauma, defined as emotional, physical, or sexual abuse or emotional or physical neglect, before the age of 18 years. Severe trauma was defined as multiple types or increased frequency of abuse.

Of the total cohort, 48% reported experiencing some childhood trauma – 21% reported severe trauma, 27% reported mild trauma, and 42% reported no childhood trauma.

Among those with trauma, 89% had a current or remitted anxiety or depressive disorder, and 11% had no psychiatric sequelae. Among participants who reported no trauma, 68% had a current or remitted disorder, and 32% had no psychiatric disorders.

At baseline, researchers assessed markers of major bodily stress systems, including the hypothalamic-pituitary-adrenal (HPA) axis, the immune-inflammatory system, and the autonomic nervous system (ANS). They examined these markers separately and cumulatively.

In one model, investigators found that levels of cortisol and inflammation were significantly elevated in those with severe childhood trauma compared to those with no childhood trauma. The effects were largest for the cumulative markers for HPA-axis, inflammation, and all stress system markers (Cohen’s d = 0.23, 0.12, and 0.25, respectively). There was no association with ANS markers.

The results were partially explained by lifestyle, said Ms. Kuzminskaite, who noted that people with severe childhood trauma tend to have a higher body mass index, smoke more, and have other unhealthy habits that may represent a “coping” mechanism for trauma.

Those who experienced childhood trauma also have higher rates of other disorders, including asthma, diabetes, and cardiovascular disease. Ms. Kuzminskaite noted that people with childhood trauma have at least double the risk of cancer in later life.

When researchers adjusted for lifestyle factors and chronic conditions, the association for cortisol was reduced and that for inflammation disappeared. However, the cumulative inflammatory markers remained significant.

Another model examined lipopolysaccharide-stimulated (LPS) immune-inflammatory markers by childhood trauma severity. This provides a more “dynamic” measure of stress systems than looking only at static circulating levels in the blood, as was done in the first model, said Ms. Kuzminskaite.

“These levels should theoretically be more affected by experiences such as childhood trauma and they are also less sensitive to lifestyle.”

Here, researchers found significant positive associations with childhood trauma, especially severe trauma, after adjusting for lifestyle and health-related covariates (cumulative index d = 0.19).

“Almost all people with childhood trauma, especially severe trauma, had LPS-stimulated cytokines upregulated,” said Ms. Kuzminskaite. “So again, there is this dysregulation of immune system functioning in these subjects.”

And again, the strongest effect was for the cumulative index of all cytokines, she said.
 

Personalized interventions

Ms. Kuzminskaite noted the importance of learning the impact of early trauma on stress responses. “The goal is to eventually have personalized interventions for people with depression or anxiety related to childhood trauma, or even preventative interventions. If we know, for example, something is going wrong with a patient’s stress systems, we can suggest some therapeutic targets.”

Investigators in Amsterdam are examining the efficacy of mifepristone, which blocks progesterone and is used along with misoprostol for medication abortions and to treat high blood sugar. “The drug is supposed to reset the stress system functioning,” said Ms. Kuzminskaite.

It’s still important to target unhealthy lifestyle habits “that are really impacting the functioning of the stress systems,” she said. Lifestyle interventions could improve the efficacy of treatments for depression, for example, she added.

Luana Marques, PhD, associate professor, department of psychiatry, Harvard Medical School, Boston, said such research is important.

“It reveals the potentially extensive and long-lasting impact of childhood trauma on functioning. The findings underscore the importance of equipping at-risk and trauma-exposed youth with evidence-based skills for managing stress,” she said.

No conflicts of interest were reported.

A version of this article first appeared on Medscape.com.

WASHINGTON – Dysregulated stress systems may help explain why childhood trauma has such a dramatic and enduring psychiatric impact, new research suggests.

“We already knew childhood trauma is associated with the later development of depressive and anxiety disorders, but it’s been unclear what makes sufferers of early trauma more likely to develop these psychiatric conditions,” study investigator Erika Kuzminskaite, PhD candidate, department of psychiatry, Amsterdam University Medical Center (UMC), the Netherlands, told this news organization.
 

“The evidence now points to unbalanced stress systems as a possible cause of this vulnerability, and now the most important question is, how we can develop preventive interventions,” she added.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Elevated cortisol, inflammation

The study included 2,779 adults from the Netherlands Study of Depression and Anxiety (NESDA). Two thirds of participants were female.

Participants retrospectively reported childhood trauma, defined as emotional, physical, or sexual abuse or emotional or physical neglect, before the age of 18 years. Severe trauma was defined as multiple types or increased frequency of abuse.

Of the total cohort, 48% reported experiencing some childhood trauma – 21% reported severe trauma, 27% reported mild trauma, and 42% reported no childhood trauma.

Among those with trauma, 89% had a current or remitted anxiety or depressive disorder, and 11% had no psychiatric sequelae. Among participants who reported no trauma, 68% had a current or remitted disorder, and 32% had no psychiatric disorders.

At baseline, researchers assessed markers of major bodily stress systems, including the hypothalamic-pituitary-adrenal (HPA) axis, the immune-inflammatory system, and the autonomic nervous system (ANS). They examined these markers separately and cumulatively.

In one model, investigators found that levels of cortisol and inflammation were significantly elevated in those with severe childhood trauma compared to those with no childhood trauma. The effects were largest for the cumulative markers for HPA-axis, inflammation, and all stress system markers (Cohen’s d = 0.23, 0.12, and 0.25, respectively). There was no association with ANS markers.

The results were partially explained by lifestyle, said Ms. Kuzminskaite, who noted that people with severe childhood trauma tend to have a higher body mass index, smoke more, and have other unhealthy habits that may represent a “coping” mechanism for trauma.

Those who experienced childhood trauma also have higher rates of other disorders, including asthma, diabetes, and cardiovascular disease. Ms. Kuzminskaite noted that people with childhood trauma have at least double the risk of cancer in later life.

When researchers adjusted for lifestyle factors and chronic conditions, the association for cortisol was reduced and that for inflammation disappeared. However, the cumulative inflammatory markers remained significant.

Another model examined lipopolysaccharide-stimulated (LPS) immune-inflammatory markers by childhood trauma severity. This provides a more “dynamic” measure of stress systems than looking only at static circulating levels in the blood, as was done in the first model, said Ms. Kuzminskaite.

“These levels should theoretically be more affected by experiences such as childhood trauma and they are also less sensitive to lifestyle.”

Here, researchers found significant positive associations with childhood trauma, especially severe trauma, after adjusting for lifestyle and health-related covariates (cumulative index d = 0.19).

“Almost all people with childhood trauma, especially severe trauma, had LPS-stimulated cytokines upregulated,” said Ms. Kuzminskaite. “So again, there is this dysregulation of immune system functioning in these subjects.”

And again, the strongest effect was for the cumulative index of all cytokines, she said.
 

Personalized interventions

Ms. Kuzminskaite noted the importance of learning the impact of early trauma on stress responses. “The goal is to eventually have personalized interventions for people with depression or anxiety related to childhood trauma, or even preventative interventions. If we know, for example, something is going wrong with a patient’s stress systems, we can suggest some therapeutic targets.”

Investigators in Amsterdam are examining the efficacy of mifepristone, which blocks progesterone and is used along with misoprostol for medication abortions and to treat high blood sugar. “The drug is supposed to reset the stress system functioning,” said Ms. Kuzminskaite.

It’s still important to target unhealthy lifestyle habits “that are really impacting the functioning of the stress systems,” she said. Lifestyle interventions could improve the efficacy of treatments for depression, for example, she added.

Luana Marques, PhD, associate professor, department of psychiatry, Harvard Medical School, Boston, said such research is important.

“It reveals the potentially extensive and long-lasting impact of childhood trauma on functioning. The findings underscore the importance of equipping at-risk and trauma-exposed youth with evidence-based skills for managing stress,” she said.

No conflicts of interest were reported.

A version of this article first appeared on Medscape.com.

WASHINGTON – Dysregulated stress systems may help explain why childhood trauma has such a dramatic and enduring psychiatric impact, new research suggests.

“We already knew childhood trauma is associated with the later development of depressive and anxiety disorders, but it’s been unclear what makes sufferers of early trauma more likely to develop these psychiatric conditions,” study investigator Erika Kuzminskaite, PhD candidate, department of psychiatry, Amsterdam University Medical Center (UMC), the Netherlands, told this news organization.
 

“The evidence now points to unbalanced stress systems as a possible cause of this vulnerability, and now the most important question is, how we can develop preventive interventions,” she added.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Elevated cortisol, inflammation

The study included 2,779 adults from the Netherlands Study of Depression and Anxiety (NESDA). Two thirds of participants were female.

Participants retrospectively reported childhood trauma, defined as emotional, physical, or sexual abuse or emotional or physical neglect, before the age of 18 years. Severe trauma was defined as multiple types or increased frequency of abuse.

Of the total cohort, 48% reported experiencing some childhood trauma – 21% reported severe trauma, 27% reported mild trauma, and 42% reported no childhood trauma.

Among those with trauma, 89% had a current or remitted anxiety or depressive disorder, and 11% had no psychiatric sequelae. Among participants who reported no trauma, 68% had a current or remitted disorder, and 32% had no psychiatric disorders.

At baseline, researchers assessed markers of major bodily stress systems, including the hypothalamic-pituitary-adrenal (HPA) axis, the immune-inflammatory system, and the autonomic nervous system (ANS). They examined these markers separately and cumulatively.

In one model, investigators found that levels of cortisol and inflammation were significantly elevated in those with severe childhood trauma compared to those with no childhood trauma. The effects were largest for the cumulative markers for HPA-axis, inflammation, and all stress system markers (Cohen’s d = 0.23, 0.12, and 0.25, respectively). There was no association with ANS markers.

The results were partially explained by lifestyle, said Ms. Kuzminskaite, who noted that people with severe childhood trauma tend to have a higher body mass index, smoke more, and have other unhealthy habits that may represent a “coping” mechanism for trauma.

Those who experienced childhood trauma also have higher rates of other disorders, including asthma, diabetes, and cardiovascular disease. Ms. Kuzminskaite noted that people with childhood trauma have at least double the risk of cancer in later life.

When researchers adjusted for lifestyle factors and chronic conditions, the association for cortisol was reduced and that for inflammation disappeared. However, the cumulative inflammatory markers remained significant.

Another model examined lipopolysaccharide-stimulated (LPS) immune-inflammatory markers by childhood trauma severity. This provides a more “dynamic” measure of stress systems than looking only at static circulating levels in the blood, as was done in the first model, said Ms. Kuzminskaite.

“These levels should theoretically be more affected by experiences such as childhood trauma and they are also less sensitive to lifestyle.”

Here, researchers found significant positive associations with childhood trauma, especially severe trauma, after adjusting for lifestyle and health-related covariates (cumulative index d = 0.19).

“Almost all people with childhood trauma, especially severe trauma, had LPS-stimulated cytokines upregulated,” said Ms. Kuzminskaite. “So again, there is this dysregulation of immune system functioning in these subjects.”

And again, the strongest effect was for the cumulative index of all cytokines, she said.
 

Personalized interventions

Ms. Kuzminskaite noted the importance of learning the impact of early trauma on stress responses. “The goal is to eventually have personalized interventions for people with depression or anxiety related to childhood trauma, or even preventative interventions. If we know, for example, something is going wrong with a patient’s stress systems, we can suggest some therapeutic targets.”

Investigators in Amsterdam are examining the efficacy of mifepristone, which blocks progesterone and is used along with misoprostol for medication abortions and to treat high blood sugar. “The drug is supposed to reset the stress system functioning,” said Ms. Kuzminskaite.

It’s still important to target unhealthy lifestyle habits “that are really impacting the functioning of the stress systems,” she said. Lifestyle interventions could improve the efficacy of treatments for depression, for example, she added.

Luana Marques, PhD, associate professor, department of psychiatry, Harvard Medical School, Boston, said such research is important.

“It reveals the potentially extensive and long-lasting impact of childhood trauma on functioning. The findings underscore the importance of equipping at-risk and trauma-exposed youth with evidence-based skills for managing stress,” she said.

No conflicts of interest were reported.

A version of this article first appeared on Medscape.com.

MANCHESTER, England – Even when C-reactive protein (CRP) levels are normal, patients with seropositive rheumatoid arthritis (RA) could still be experiencing significant disease that persists over time, researchers from University College London have found.

Similar levels of joint erosion and disease activity were observed over a 5-year period; researchers compared patients who had high CRP levels (> 5 mg/L)* with patients whose CRP levels were consistently normal (< 5 mg/L) at the time of an ultrasound-proven disease flare.

“Our data suggests that the phenotype of normal CRP represents at least 5% of our cohort,” Bhavika Sethi, MBChB, reported in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

“They are more likely to require biologic treatment, and this continues on even though they have equivalent DAS28 [disease activity score in 28 joints] and risk of joint damage” to high-CRP patients, she said.

These patients are a significant minority, Dr. Sethi added, and “we need to think about how we provide care for them and allocate resources.”
 

Diagnostic delay and poor outcomes previously seen

The study is a continuation of a larger project, the corresponding author for the poster, Matthew Hutchinson, MBChB, told this news organization.

A few years ago, Dr. Hutchinson explained, a subset of patients with normal CRP levels during RA flares were identified and were found to be more likely to have experienced diagnostic delay and worse outcomes than did those with high CRP levels.

The aim of the current study was to see whether those findings persisted by longitudinally assessing patient records and seeing what happened 1, 2, and 5 years later. They evaluated 312 patients with seropositive RA, of whom 28 had CRP < 5 mg/L as well as active disease, which was determined on the basis of a DAS28 > 4.5. Of those 28 patients, 16 had persistently low CRP (< 5 mg/L) despite active disease. All patients who were taking tocilizumab were excluded from the study because of its CRP-lowering properties.

“Our project was showing that this group of people exist, trying to characterize them a little better” and that the study serves as a “jumping-off point” for future research, Dr. Hutchinson said.

The study was also conducted to “make people more aware of [patients with normal CRP during flare], because treating clinicians could be falsely reassured by a normal CRP,” he added. “Patients in front of them could actually be undertreated and have worse outcomes if [it is] not picked up,” Dr. Hutchinson suggested.

In comparison with those with high CRP levels, those with normal CRP levels were more likely to be receiving biologic treatment at 5 years (76.6% vs. 44.4%; P =  .0323).

At 5 years, DAS28 was similar (P = .9615) among patients with normal CRP levels and those with high CRP levels, at a median of 2.8 and 3.2, respectively. A similar percentage of patients in these two groups also had joint damage (63.3% vs. 71.4%; P = .7384).
 

Don’t rely only on CRP to diagnose and manage RA flares

“CRP is a generic inflammatory marker in most people,” Dr. Hutchinson said. “In the majority of situations when either there is inflammation or an infection, certainly if it’s systemic infection or inflammation, you will find CRP being elevated on the blood tests.”

For someone presenting with joint pain, high CRP can be a useful indicator that it’s more of an inflammatory process than physical injury, he added. CRP is also frequently used to calculate DAS28 to monitor disease activity.

“This study highlights that CRP may be normal during flares in some people with RA,” Jeffrey A. Sparks, MD, told this news organization.

“These patients may still require advanced therapies and can accrue damage,” the rheumatologist from Brigham and Women’s Hospital and Harvard University, Boston, added.

“Clinicians should not only rely on CRP to diagnose and manage RA flares,” said Dr. Sparks, who was not involved in the study.

The study was independently supported. Dr. Hutchinson and Dr. Sethi report no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care; he has received research support from Bristol-Myers Squibb and has performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.

*Correction, 5/9/2023: This article has been updated to correct the units for C-reactive protein from mg/dL to mg/L.

A version of this article first appeared on Medscape.com.

MANCHESTER, England – Even when C-reactive protein (CRP) levels are normal, patients with seropositive rheumatoid arthritis (RA) could still be experiencing significant disease that persists over time, researchers from University College London have found.

Similar levels of joint erosion and disease activity were observed over a 5-year period; researchers compared patients who had high CRP levels (> 5 mg/L)* with patients whose CRP levels were consistently normal (< 5 mg/L) at the time of an ultrasound-proven disease flare.

“Our data suggests that the phenotype of normal CRP represents at least 5% of our cohort,” Bhavika Sethi, MBChB, reported in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

“They are more likely to require biologic treatment, and this continues on even though they have equivalent DAS28 [disease activity score in 28 joints] and risk of joint damage” to high-CRP patients, she said.

These patients are a significant minority, Dr. Sethi added, and “we need to think about how we provide care for them and allocate resources.”
 

Diagnostic delay and poor outcomes previously seen

The study is a continuation of a larger project, the corresponding author for the poster, Matthew Hutchinson, MBChB, told this news organization.

A few years ago, Dr. Hutchinson explained, a subset of patients with normal CRP levels during RA flares were identified and were found to be more likely to have experienced diagnostic delay and worse outcomes than did those with high CRP levels.

The aim of the current study was to see whether those findings persisted by longitudinally assessing patient records and seeing what happened 1, 2, and 5 years later. They evaluated 312 patients with seropositive RA, of whom 28 had CRP < 5 mg/L as well as active disease, which was determined on the basis of a DAS28 > 4.5. Of those 28 patients, 16 had persistently low CRP (< 5 mg/L) despite active disease. All patients who were taking tocilizumab were excluded from the study because of its CRP-lowering properties.

“Our project was showing that this group of people exist, trying to characterize them a little better” and that the study serves as a “jumping-off point” for future research, Dr. Hutchinson said.

The study was also conducted to “make people more aware of [patients with normal CRP during flare], because treating clinicians could be falsely reassured by a normal CRP,” he added. “Patients in front of them could actually be undertreated and have worse outcomes if [it is] not picked up,” Dr. Hutchinson suggested.

In comparison with those with high CRP levels, those with normal CRP levels were more likely to be receiving biologic treatment at 5 years (76.6% vs. 44.4%; P =  .0323).

At 5 years, DAS28 was similar (P = .9615) among patients with normal CRP levels and those with high CRP levels, at a median of 2.8 and 3.2, respectively. A similar percentage of patients in these two groups also had joint damage (63.3% vs. 71.4%; P = .7384).
 

Don’t rely only on CRP to diagnose and manage RA flares

“CRP is a generic inflammatory marker in most people,” Dr. Hutchinson said. “In the majority of situations when either there is inflammation or an infection, certainly if it’s systemic infection or inflammation, you will find CRP being elevated on the blood tests.”

For someone presenting with joint pain, high CRP can be a useful indicator that it’s more of an inflammatory process than physical injury, he added. CRP is also frequently used to calculate DAS28 to monitor disease activity.

“This study highlights that CRP may be normal during flares in some people with RA,” Jeffrey A. Sparks, MD, told this news organization.

“These patients may still require advanced therapies and can accrue damage,” the rheumatologist from Brigham and Women’s Hospital and Harvard University, Boston, added.

“Clinicians should not only rely on CRP to diagnose and manage RA flares,” said Dr. Sparks, who was not involved in the study.

The study was independently supported. Dr. Hutchinson and Dr. Sethi report no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care; he has received research support from Bristol-Myers Squibb and has performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.

*Correction, 5/9/2023: This article has been updated to correct the units for C-reactive protein from mg/dL to mg/L.

A version of this article first appeared on Medscape.com.

MANCHESTER, England – Even when C-reactive protein (CRP) levels are normal, patients with seropositive rheumatoid arthritis (RA) could still be experiencing significant disease that persists over time, researchers from University College London have found.

Similar levels of joint erosion and disease activity were observed over a 5-year period; researchers compared patients who had high CRP levels (> 5 mg/L)* with patients whose CRP levels were consistently normal (< 5 mg/L) at the time of an ultrasound-proven disease flare.

“Our data suggests that the phenotype of normal CRP represents at least 5% of our cohort,” Bhavika Sethi, MBChB, reported in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

“They are more likely to require biologic treatment, and this continues on even though they have equivalent DAS28 [disease activity score in 28 joints] and risk of joint damage” to high-CRP patients, she said.

These patients are a significant minority, Dr. Sethi added, and “we need to think about how we provide care for them and allocate resources.”
 

Diagnostic delay and poor outcomes previously seen

The study is a continuation of a larger project, the corresponding author for the poster, Matthew Hutchinson, MBChB, told this news organization.

A few years ago, Dr. Hutchinson explained, a subset of patients with normal CRP levels during RA flares were identified and were found to be more likely to have experienced diagnostic delay and worse outcomes than did those with high CRP levels.

The aim of the current study was to see whether those findings persisted by longitudinally assessing patient records and seeing what happened 1, 2, and 5 years later. They evaluated 312 patients with seropositive RA, of whom 28 had CRP < 5 mg/L as well as active disease, which was determined on the basis of a DAS28 > 4.5. Of those 28 patients, 16 had persistently low CRP (< 5 mg/L) despite active disease. All patients who were taking tocilizumab were excluded from the study because of its CRP-lowering properties.

“Our project was showing that this group of people exist, trying to characterize them a little better” and that the study serves as a “jumping-off point” for future research, Dr. Hutchinson said.

The study was also conducted to “make people more aware of [patients with normal CRP during flare], because treating clinicians could be falsely reassured by a normal CRP,” he added. “Patients in front of them could actually be undertreated and have worse outcomes if [it is] not picked up,” Dr. Hutchinson suggested.

In comparison with those with high CRP levels, those with normal CRP levels were more likely to be receiving biologic treatment at 5 years (76.6% vs. 44.4%; P =  .0323).

At 5 years, DAS28 was similar (P = .9615) among patients with normal CRP levels and those with high CRP levels, at a median of 2.8 and 3.2, respectively. A similar percentage of patients in these two groups also had joint damage (63.3% vs. 71.4%; P = .7384).
 

Don’t rely only on CRP to diagnose and manage RA flares

“CRP is a generic inflammatory marker in most people,” Dr. Hutchinson said. “In the majority of situations when either there is inflammation or an infection, certainly if it’s systemic infection or inflammation, you will find CRP being elevated on the blood tests.”

For someone presenting with joint pain, high CRP can be a useful indicator that it’s more of an inflammatory process than physical injury, he added. CRP is also frequently used to calculate DAS28 to monitor disease activity.

“This study highlights that CRP may be normal during flares in some people with RA,” Jeffrey A. Sparks, MD, told this news organization.

“These patients may still require advanced therapies and can accrue damage,” the rheumatologist from Brigham and Women’s Hospital and Harvard University, Boston, added.

“Clinicians should not only rely on CRP to diagnose and manage RA flares,” said Dr. Sparks, who was not involved in the study.

The study was independently supported. Dr. Hutchinson and Dr. Sethi report no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care; he has received research support from Bristol-Myers Squibb and has performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.

*Correction, 5/9/2023: This article has been updated to correct the units for C-reactive protein from mg/dL to mg/L.

A version of this article first appeared on Medscape.com.

The largest multicenter randomized trial to date of CT angiography before left atrial appendage closure (LAAC) to treat atrial fibrillation has added to the evidence that the imaging technique on top of transesophageal echocardiography achieves a higher degree of short- and long-term success than TEE alone.

The results are from a subanalysis of the Swiss-Apero trial, a randomized comparative trial of the Watchman and Amulet devices for LAAC, which published results in Circulation.

“Our observational data support to use of CT for LAAC procedure planning,” senior investigator Lorenz Räber, MD, PhD, said in an interview. “This is not very surprising given the high variability of the LAA anatomy and the associated complexity of the procedure.” Dr. Räber is director of the catheterization laboratory at Inselspital, Bern (Switzerland) University Hospital.

The study, published online in JACC: Cardiovascular Interventions, included 219 LAAC procedures in which the operators performed coronary CT angiography (CTTA) beforehand. When the investigators designed the study, LAAC procedures were typically planned using TEE alone, and so participating operators were blinded to preprocedural CCTA imaging. Soon after the study launch, European cardiology societies issued a consensus statement that included CCTA as an option for procedure planning. So the Swiss-Apero investigators changed the subanalysis protocol to unblind the operators – that is, they were permitted to plan LAAC procedures with CCTA imaging in addition to TEE. In this subanalysis, most patients had implantation with blinding to CCTA (57.9% vs. 41.2%).
 

Study results

The subanalysis determined that operator unblinding to preprocedural CCTA resulted in better success with LAAC, both in the short term, at 93.5% vs. 81.1% (P = .009; adjusted odds ratio, 2.76; 95% confidence interval, 1.05-7.29; P = .40) and the long term, at 83.7% vs. 72.4% (P = .050; aOR, 2.12; 95% CI, 1.03-4.35; P = .041).

Dr. Räber noted that this is only the third study to date that examined the potential impact of preprocedural CCTA plus TEE. One was a small study of 24 consecutive LAAC procedures with the Watchman device that compared TEE alone and CCTA plus TEE, finding better outcomes in the group that had both imaging modalities . A larger, single-center cohort study of 485 LAAC Watchman procedures found that CCTA resulted in faster operation times and higher successful device implantation rates, but no significant difference in procedural complications.

Dr. Räber explained why his group’s subanalysis may have found a clinical benefit with CCTA on top of TEE. “Our study was much larger, as compared to the randomized clinical trial, and there was no selection bias as in the second study mentioned before, as operators did not have the option to decide whether or not to assess the CCTA prior to the procedure,” he said. “Finally, in the previous studies there was no random allocation of device type” – that is, Amulet versus Watchman.

One study limitation Dr. Räber noted was that significantly more patients in the blinded group were discharged with dual-antiplatelet therapy. “The lower rate of procedure complications observed in unblinded procedures was mostly driven by a lower number of major bleedings and in particular of pericardial tamponade,” he said. “We cannot therefore exclude that the higher percentage of patients under dual-antiplatelet therapy in the CCTA-blinded group might have favored this difference.”

However, he noted the investigators corrected their analysis to account for differences between the groups. “Importantly, the numerical excess in major procedural bleeding was observed within both the single-antiplatelet therapy and dual-antiplatelet therapy subgroups of the TEE-only group.”

In an accompanying editorial, coauthors Brian O’Neill, MD, and Dee Dee Wang, MD, both with the Center for Structural Heard Disease at Henry Ford Hospital in Detroit, noted that the Swiss-Apero subanalysis “reinforced” the benefit of CCTA before LAAC.  

“This study demonstrated, for the first time, improved short- and long-term procedural success using CT in addition to TEE for left atrial appendage occlusion,” Dr. O’Neill said in an interview. “This particular study may serve as a guide to an adequately powered randomized trial of CT versus TEE in left atrial appendage occlusion.” Future LAAC trials should incorporate preprocedural CCTA.

Dr. O’Neill noted that, as a subanalysis of a randomized trial, the “results are hypothesis generating.” However, he added, “the results are in line with several previous studies of CT versus TEE in left atrial appendage occlusion.”

Dr Räber disclosed financial relationships with Abbott Vascular, Boston Scientific, Biotronik, Infraredx, Heartflow, Sanofi, Regeneron, Amgen, AstraZeneca, CSL Behring, Canon, Occlutech, and Vifor. Dr. O’Neill disclosed financial relationships with Edwards Lifesciences, Medtronic, and Abbott Vascular.

The largest multicenter randomized trial to date of CT angiography before left atrial appendage closure (LAAC) to treat atrial fibrillation has added to the evidence that the imaging technique on top of transesophageal echocardiography achieves a higher degree of short- and long-term success than TEE alone.

The results are from a subanalysis of the Swiss-Apero trial, a randomized comparative trial of the Watchman and Amulet devices for LAAC, which published results in Circulation.

“Our observational data support to use of CT for LAAC procedure planning,” senior investigator Lorenz Räber, MD, PhD, said in an interview. “This is not very surprising given the high variability of the LAA anatomy and the associated complexity of the procedure.” Dr. Räber is director of the catheterization laboratory at Inselspital, Bern (Switzerland) University Hospital.

The study, published online in JACC: Cardiovascular Interventions, included 219 LAAC procedures in which the operators performed coronary CT angiography (CTTA) beforehand. When the investigators designed the study, LAAC procedures were typically planned using TEE alone, and so participating operators were blinded to preprocedural CCTA imaging. Soon after the study launch, European cardiology societies issued a consensus statement that included CCTA as an option for procedure planning. So the Swiss-Apero investigators changed the subanalysis protocol to unblind the operators – that is, they were permitted to plan LAAC procedures with CCTA imaging in addition to TEE. In this subanalysis, most patients had implantation with blinding to CCTA (57.9% vs. 41.2%).
 

Study results

The subanalysis determined that operator unblinding to preprocedural CCTA resulted in better success with LAAC, both in the short term, at 93.5% vs. 81.1% (P = .009; adjusted odds ratio, 2.76; 95% confidence interval, 1.05-7.29; P = .40) and the long term, at 83.7% vs. 72.4% (P = .050; aOR, 2.12; 95% CI, 1.03-4.35; P = .041).

Dr. Räber noted that this is only the third study to date that examined the potential impact of preprocedural CCTA plus TEE. One was a small study of 24 consecutive LAAC procedures with the Watchman device that compared TEE alone and CCTA plus TEE, finding better outcomes in the group that had both imaging modalities . A larger, single-center cohort study of 485 LAAC Watchman procedures found that CCTA resulted in faster operation times and higher successful device implantation rates, but no significant difference in procedural complications.

Dr. Räber explained why his group’s subanalysis may have found a clinical benefit with CCTA on top of TEE. “Our study was much larger, as compared to the randomized clinical trial, and there was no selection bias as in the second study mentioned before, as operators did not have the option to decide whether or not to assess the CCTA prior to the procedure,” he said. “Finally, in the previous studies there was no random allocation of device type” – that is, Amulet versus Watchman.

One study limitation Dr. Räber noted was that significantly more patients in the blinded group were discharged with dual-antiplatelet therapy. “The lower rate of procedure complications observed in unblinded procedures was mostly driven by a lower number of major bleedings and in particular of pericardial tamponade,” he said. “We cannot therefore exclude that the higher percentage of patients under dual-antiplatelet therapy in the CCTA-blinded group might have favored this difference.”

However, he noted the investigators corrected their analysis to account for differences between the groups. “Importantly, the numerical excess in major procedural bleeding was observed within both the single-antiplatelet therapy and dual-antiplatelet therapy subgroups of the TEE-only group.”

In an accompanying editorial, coauthors Brian O’Neill, MD, and Dee Dee Wang, MD, both with the Center for Structural Heard Disease at Henry Ford Hospital in Detroit, noted that the Swiss-Apero subanalysis “reinforced” the benefit of CCTA before LAAC.  

“This study demonstrated, for the first time, improved short- and long-term procedural success using CT in addition to TEE for left atrial appendage occlusion,” Dr. O’Neill said in an interview. “This particular study may serve as a guide to an adequately powered randomized trial of CT versus TEE in left atrial appendage occlusion.” Future LAAC trials should incorporate preprocedural CCTA.

Dr. O’Neill noted that, as a subanalysis of a randomized trial, the “results are hypothesis generating.” However, he added, “the results are in line with several previous studies of CT versus TEE in left atrial appendage occlusion.”

Dr Räber disclosed financial relationships with Abbott Vascular, Boston Scientific, Biotronik, Infraredx, Heartflow, Sanofi, Regeneron, Amgen, AstraZeneca, CSL Behring, Canon, Occlutech, and Vifor. Dr. O’Neill disclosed financial relationships with Edwards Lifesciences, Medtronic, and Abbott Vascular.

The largest multicenter randomized trial to date of CT angiography before left atrial appendage closure (LAAC) to treat atrial fibrillation has added to the evidence that the imaging technique on top of transesophageal echocardiography achieves a higher degree of short- and long-term success than TEE alone.

The results are from a subanalysis of the Swiss-Apero trial, a randomized comparative trial of the Watchman and Amulet devices for LAAC, which published results in Circulation.

“Our observational data support to use of CT for LAAC procedure planning,” senior investigator Lorenz Räber, MD, PhD, said in an interview. “This is not very surprising given the high variability of the LAA anatomy and the associated complexity of the procedure.” Dr. Räber is director of the catheterization laboratory at Inselspital, Bern (Switzerland) University Hospital.

The study, published online in JACC: Cardiovascular Interventions, included 219 LAAC procedures in which the operators performed coronary CT angiography (CTTA) beforehand. When the investigators designed the study, LAAC procedures were typically planned using TEE alone, and so participating operators were blinded to preprocedural CCTA imaging. Soon after the study launch, European cardiology societies issued a consensus statement that included CCTA as an option for procedure planning. So the Swiss-Apero investigators changed the subanalysis protocol to unblind the operators – that is, they were permitted to plan LAAC procedures with CCTA imaging in addition to TEE. In this subanalysis, most patients had implantation with blinding to CCTA (57.9% vs. 41.2%).
 

Study results

The subanalysis determined that operator unblinding to preprocedural CCTA resulted in better success with LAAC, both in the short term, at 93.5% vs. 81.1% (P = .009; adjusted odds ratio, 2.76; 95% confidence interval, 1.05-7.29; P = .40) and the long term, at 83.7% vs. 72.4% (P = .050; aOR, 2.12; 95% CI, 1.03-4.35; P = .041).

Dr. Räber noted that this is only the third study to date that examined the potential impact of preprocedural CCTA plus TEE. One was a small study of 24 consecutive LAAC procedures with the Watchman device that compared TEE alone and CCTA plus TEE, finding better outcomes in the group that had both imaging modalities . A larger, single-center cohort study of 485 LAAC Watchman procedures found that CCTA resulted in faster operation times and higher successful device implantation rates, but no significant difference in procedural complications.

Dr. Räber explained why his group’s subanalysis may have found a clinical benefit with CCTA on top of TEE. “Our study was much larger, as compared to the randomized clinical trial, and there was no selection bias as in the second study mentioned before, as operators did not have the option to decide whether or not to assess the CCTA prior to the procedure,” he said. “Finally, in the previous studies there was no random allocation of device type” – that is, Amulet versus Watchman.

One study limitation Dr. Räber noted was that significantly more patients in the blinded group were discharged with dual-antiplatelet therapy. “The lower rate of procedure complications observed in unblinded procedures was mostly driven by a lower number of major bleedings and in particular of pericardial tamponade,” he said. “We cannot therefore exclude that the higher percentage of patients under dual-antiplatelet therapy in the CCTA-blinded group might have favored this difference.”

However, he noted the investigators corrected their analysis to account for differences between the groups. “Importantly, the numerical excess in major procedural bleeding was observed within both the single-antiplatelet therapy and dual-antiplatelet therapy subgroups of the TEE-only group.”

In an accompanying editorial, coauthors Brian O’Neill, MD, and Dee Dee Wang, MD, both with the Center for Structural Heard Disease at Henry Ford Hospital in Detroit, noted that the Swiss-Apero subanalysis “reinforced” the benefit of CCTA before LAAC.  

“This study demonstrated, for the first time, improved short- and long-term procedural success using CT in addition to TEE for left atrial appendage occlusion,” Dr. O’Neill said in an interview. “This particular study may serve as a guide to an adequately powered randomized trial of CT versus TEE in left atrial appendage occlusion.” Future LAAC trials should incorporate preprocedural CCTA.

Dr. O’Neill noted that, as a subanalysis of a randomized trial, the “results are hypothesis generating.” However, he added, “the results are in line with several previous studies of CT versus TEE in left atrial appendage occlusion.”

Dr Räber disclosed financial relationships with Abbott Vascular, Boston Scientific, Biotronik, Infraredx, Heartflow, Sanofi, Regeneron, Amgen, AstraZeneca, CSL Behring, Canon, Occlutech, and Vifor. Dr. O’Neill disclosed financial relationships with Edwards Lifesciences, Medtronic, and Abbott Vascular.

PHOENIX – Treating superficial and nodular basal cell cancers (BCCs) with an apoptotic process induced by controlled hyperthermia resulted in strong histologic clearance of tumors, an interim report from an ongoing study showed.

“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.

Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.

The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm² pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm² pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.

To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.

Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.

“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm² at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm² until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”

Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”

In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.

“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”

The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.

PHOENIX – Treating superficial and nodular basal cell cancers (BCCs) with an apoptotic process induced by controlled hyperthermia resulted in strong histologic clearance of tumors, an interim report from an ongoing study showed.

“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.

Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.

The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm² pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm² pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.

To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.

Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.

“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm² at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm² until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”

Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”

In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.

“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”

The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.

PHOENIX – Treating superficial and nodular basal cell cancers (BCCs) with an apoptotic process induced by controlled hyperthermia resulted in strong histologic clearance of tumors, an interim report from an ongoing study showed.

“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.

Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.

The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm² pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm² pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.

To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.

Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.

“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm² at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm² until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”

Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”

In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.

“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”

The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.

BOSTON – In patients with radiologically isolated syndrome (RIS) predictive of multiple sclerosis (MS), teriflunomide reduced the risk of a demyelinating event by more than 60% over a 2-year period, according to a double-blind, phase 3 trial presented in the Emerging Science session of the 2023 annual meeting of the American Academy of Neurology.

Bruce Jancin/MDedge News

“These data add to the evidence that early immunomodulation offers clinical benefit even in the presymptomatic phase of MS,” reported Christine Lebrun-Frenay, MD, PhD, head of inflammatory neurological disorders research unit, University of Nice, France. This is the second study to show a benefit from a disease-modifying therapy in asymptomatic RIS patients. The ARISE study, which was presented at the 2022 European Committee for Treatment and Research in MS and has now been published, compared 240 mg of twice-daily dimethyl fumarate with placebo. Dimethyl fumarate was associated with an 82% (hazard ratio, 0.18; P = .007) reduction in the risk of a first demyelinating event after 96 weeks of follow-up.
 

TERIS trial data

In the new study, called TERIS, the design and outcomes were similar to the ARISE study. Eighty-nine patients meeting standard criteria for RIS were randomized to 14 mg of once-daily teriflunomide or placebo. The majority (71%) were female, and the mean age was 39.8 years. At the time of RIS diagnosis, the mean age was 38 years. At study entry, standardized MRI studies were performed of the brain and spinal cord.

During 2 years of follow-up, 8 of 28 demyelinating events were observed in the active treatment group. The remaining 20 occurred in the placebo group. This translated to a 63% reduction (HR, 0.37; P = .018) in favor of teriflunomide. When graphed, the curves separated at about 6 months and then widened progressively over time.

Distinct from clinically isolated syndrome (CIS), which describes individuals who have a symptomatic episode consistent with a demyelinating event, RIS is based primarily on an MRI that shows lesions highly suggestive of MS. Neither confirms the MS diagnosis, but both are associated with a high likelihood of eventually meeting MS diagnostic criteria. The ARISE and TERIS studies now support therapy to delay demyelinating events.

“With more and more people having brain scans for various reasons, such as headache or head trauma, more of these cases are being discovered,” Dr. Lebrun-Frenay said.
 

Caution warranted when interpreting the findings

The data support the theory that treatment should begin early in patients with a high likelihood of developing symptomatic MS on the basis of brain lesions. It is logical to assume that preventing damage to the myelin will reduce or delay permanent symptoms and permanent neurologic impairment, but Dr. Lebrun-Frenay suggested that the available data from ARISE and TERIS are not practice changing even though both were multicenter double-blind trials.

“More data from larger groups of patients are needed to confirm the findings,” she said. She expressed concern about not adhering to strict criteria to diagnosis RIS.

“It is important that medical professionals are cautious,” she said, citing the risk of misdiagnosis of pathology of MRI that leads to treatment of patients with a low risk of developing symptomatic MS.

Teriflunomide and dimethyl fumarate, which have long been available as first-line therapies in relapsing-remitting MS, are generally well tolerated. In the TERIS and ARISE studies, mild or moderate events occurred more commonly in the active treatment than the placebo arms, but there were no serious adverse events. However, both can produce more serious adverse events, which, in the case of teriflunomide, include liver toxicity leading to injury and liver failure.
 

Challenging the traditional definition of MS

The author of the ARISE study, Darin T. Okuda, MD, a professor of neurology at the UT Southwestern Medical Center, Dallas, indicated that his study, now reinforced by the TERIS study, challenges the definition of MS.

“Both ARISE and TERIS demonstrated a significant reduction in seminal clinical event rates related to inflammatory demyelination,” Dr. Okuda said in an interview. They provide evidence that patients are at high risk of the demyelinating events that characterize MS. Given the potential difficulty for accessing therapies of benefit, “how we define multiple sclerosis is highly important.”

“Individuals of younger age with abnormal spinal cord MRI studies along with other paraclinical features related to risk for a first event may be the most ideal group to treat,” he said. However, he agreed with Dr. Lebrun-Frenay that it is not yet clear which RIS patients are the most appropriate candidates.

“Gaining a more refined sense of who we should treat will require more work,” he said.

These data are likely to change the orientation toward RIS, according to Melina Hosseiny, MD, department of radiology, University of California, Los Angeles, Medical Center. She noted that the relationship between RIS and increased risk of MS has long been recognized, and the risk increases with specific features on imaging.

“Studies have shown that spinal cord lesions are associated with a greater than 50% chance of converting to MS,” said Dr. Hosseiny, who was the lead author of a review article on RIS. “Identifying such imaging findings can help identify patients who may benefit from disease-modifying medications.”

Dr. Lebrun-Frenay reports no potential conflicts of interest. Dr. Okuda has financial relationships with Alexion, Biogen, Celgene, EMD Serono, Genzyme, TG Therapeutics, and VielaBio. Dr. Hosseiny reports no potential conflicts of interest.

BOSTON – In patients with radiologically isolated syndrome (RIS) predictive of multiple sclerosis (MS), teriflunomide reduced the risk of a demyelinating event by more than 60% over a 2-year period, according to a double-blind, phase 3 trial presented in the Emerging Science session of the 2023 annual meeting of the American Academy of Neurology.

Bruce Jancin/MDedge News

“These data add to the evidence that early immunomodulation offers clinical benefit even in the presymptomatic phase of MS,” reported Christine Lebrun-Frenay, MD, PhD, head of inflammatory neurological disorders research unit, University of Nice, France. This is the second study to show a benefit from a disease-modifying therapy in asymptomatic RIS patients. The ARISE study, which was presented at the 2022 European Committee for Treatment and Research in MS and has now been published, compared 240 mg of twice-daily dimethyl fumarate with placebo. Dimethyl fumarate was associated with an 82% (hazard ratio, 0.18; P = .007) reduction in the risk of a first demyelinating event after 96 weeks of follow-up.
 

TERIS trial data

In the new study, called TERIS, the design and outcomes were similar to the ARISE study. Eighty-nine patients meeting standard criteria for RIS were randomized to 14 mg of once-daily teriflunomide or placebo. The majority (71%) were female, and the mean age was 39.8 years. At the time of RIS diagnosis, the mean age was 38 years. At study entry, standardized MRI studies were performed of the brain and spinal cord.

During 2 years of follow-up, 8 of 28 demyelinating events were observed in the active treatment group. The remaining 20 occurred in the placebo group. This translated to a 63% reduction (HR, 0.37; P = .018) in favor of teriflunomide. When graphed, the curves separated at about 6 months and then widened progressively over time.

Distinct from clinically isolated syndrome (CIS), which describes individuals who have a symptomatic episode consistent with a demyelinating event, RIS is based primarily on an MRI that shows lesions highly suggestive of MS. Neither confirms the MS diagnosis, but both are associated with a high likelihood of eventually meeting MS diagnostic criteria. The ARISE and TERIS studies now support therapy to delay demyelinating events.

“With more and more people having brain scans for various reasons, such as headache or head trauma, more of these cases are being discovered,” Dr. Lebrun-Frenay said.
 

Caution warranted when interpreting the findings

The data support the theory that treatment should begin early in patients with a high likelihood of developing symptomatic MS on the basis of brain lesions. It is logical to assume that preventing damage to the myelin will reduce or delay permanent symptoms and permanent neurologic impairment, but Dr. Lebrun-Frenay suggested that the available data from ARISE and TERIS are not practice changing even though both were multicenter double-blind trials.

“More data from larger groups of patients are needed to confirm the findings,” she said. She expressed concern about not adhering to strict criteria to diagnosis RIS.

“It is important that medical professionals are cautious,” she said, citing the risk of misdiagnosis of pathology of MRI that leads to treatment of patients with a low risk of developing symptomatic MS.

Teriflunomide and dimethyl fumarate, which have long been available as first-line therapies in relapsing-remitting MS, are generally well tolerated. In the TERIS and ARISE studies, mild or moderate events occurred more commonly in the active treatment than the placebo arms, but there were no serious adverse events. However, both can produce more serious adverse events, which, in the case of teriflunomide, include liver toxicity leading to injury and liver failure.
 

Challenging the traditional definition of MS

The author of the ARISE study, Darin T. Okuda, MD, a professor of neurology at the UT Southwestern Medical Center, Dallas, indicated that his study, now reinforced by the TERIS study, challenges the definition of MS.

“Both ARISE and TERIS demonstrated a significant reduction in seminal clinical event rates related to inflammatory demyelination,” Dr. Okuda said in an interview. They provide evidence that patients are at high risk of the demyelinating events that characterize MS. Given the potential difficulty for accessing therapies of benefit, “how we define multiple sclerosis is highly important.”

“Individuals of younger age with abnormal spinal cord MRI studies along with other paraclinical features related to risk for a first event may be the most ideal group to treat,” he said. However, he agreed with Dr. Lebrun-Frenay that it is not yet clear which RIS patients are the most appropriate candidates.

“Gaining a more refined sense of who we should treat will require more work,” he said.

These data are likely to change the orientation toward RIS, according to Melina Hosseiny, MD, department of radiology, University of California, Los Angeles, Medical Center. She noted that the relationship between RIS and increased risk of MS has long been recognized, and the risk increases with specific features on imaging.

“Studies have shown that spinal cord lesions are associated with a greater than 50% chance of converting to MS,” said Dr. Hosseiny, who was the lead author of a review article on RIS. “Identifying such imaging findings can help identify patients who may benefit from disease-modifying medications.”

Dr. Lebrun-Frenay reports no potential conflicts of interest. Dr. Okuda has financial relationships with Alexion, Biogen, Celgene, EMD Serono, Genzyme, TG Therapeutics, and VielaBio. Dr. Hosseiny reports no potential conflicts of interest.

BOSTON – In patients with radiologically isolated syndrome (RIS) predictive of multiple sclerosis (MS), teriflunomide reduced the risk of a demyelinating event by more than 60% over a 2-year period, according to a double-blind, phase 3 trial presented in the Emerging Science session of the 2023 annual meeting of the American Academy of Neurology.

Bruce Jancin/MDedge News

“These data add to the evidence that early immunomodulation offers clinical benefit even in the presymptomatic phase of MS,” reported Christine Lebrun-Frenay, MD, PhD, head of inflammatory neurological disorders research unit, University of Nice, France. This is the second study to show a benefit from a disease-modifying therapy in asymptomatic RIS patients. The ARISE study, which was presented at the 2022 European Committee for Treatment and Research in MS and has now been published, compared 240 mg of twice-daily dimethyl fumarate with placebo. Dimethyl fumarate was associated with an 82% (hazard ratio, 0.18; P = .007) reduction in the risk of a first demyelinating event after 96 weeks of follow-up.
 

TERIS trial data

In the new study, called TERIS, the design and outcomes were similar to the ARISE study. Eighty-nine patients meeting standard criteria for RIS were randomized to 14 mg of once-daily teriflunomide or placebo. The majority (71%) were female, and the mean age was 39.8 years. At the time of RIS diagnosis, the mean age was 38 years. At study entry, standardized MRI studies were performed of the brain and spinal cord.

During 2 years of follow-up, 8 of 28 demyelinating events were observed in the active treatment group. The remaining 20 occurred in the placebo group. This translated to a 63% reduction (HR, 0.37; P = .018) in favor of teriflunomide. When graphed, the curves separated at about 6 months and then widened progressively over time.

Distinct from clinically isolated syndrome (CIS), which describes individuals who have a symptomatic episode consistent with a demyelinating event, RIS is based primarily on an MRI that shows lesions highly suggestive of MS. Neither confirms the MS diagnosis, but both are associated with a high likelihood of eventually meeting MS diagnostic criteria. The ARISE and TERIS studies now support therapy to delay demyelinating events.

“With more and more people having brain scans for various reasons, such as headache or head trauma, more of these cases are being discovered,” Dr. Lebrun-Frenay said.
 

Caution warranted when interpreting the findings

The data support the theory that treatment should begin early in patients with a high likelihood of developing symptomatic MS on the basis of brain lesions. It is logical to assume that preventing damage to the myelin will reduce or delay permanent symptoms and permanent neurologic impairment, but Dr. Lebrun-Frenay suggested that the available data from ARISE and TERIS are not practice changing even though both were multicenter double-blind trials.

“More data from larger groups of patients are needed to confirm the findings,” she said. She expressed concern about not adhering to strict criteria to diagnosis RIS.

“It is important that medical professionals are cautious,” she said, citing the risk of misdiagnosis of pathology of MRI that leads to treatment of patients with a low risk of developing symptomatic MS.

Teriflunomide and dimethyl fumarate, which have long been available as first-line therapies in relapsing-remitting MS, are generally well tolerated. In the TERIS and ARISE studies, mild or moderate events occurred more commonly in the active treatment than the placebo arms, but there were no serious adverse events. However, both can produce more serious adverse events, which, in the case of teriflunomide, include liver toxicity leading to injury and liver failure.
 

Challenging the traditional definition of MS

The author of the ARISE study, Darin T. Okuda, MD, a professor of neurology at the UT Southwestern Medical Center, Dallas, indicated that his study, now reinforced by the TERIS study, challenges the definition of MS.

“Both ARISE and TERIS demonstrated a significant reduction in seminal clinical event rates related to inflammatory demyelination,” Dr. Okuda said in an interview. They provide evidence that patients are at high risk of the demyelinating events that characterize MS. Given the potential difficulty for accessing therapies of benefit, “how we define multiple sclerosis is highly important.”

“Individuals of younger age with abnormal spinal cord MRI studies along with other paraclinical features related to risk for a first event may be the most ideal group to treat,” he said. However, he agreed with Dr. Lebrun-Frenay that it is not yet clear which RIS patients are the most appropriate candidates.

“Gaining a more refined sense of who we should treat will require more work,” he said.

These data are likely to change the orientation toward RIS, according to Melina Hosseiny, MD, department of radiology, University of California, Los Angeles, Medical Center. She noted that the relationship between RIS and increased risk of MS has long been recognized, and the risk increases with specific features on imaging.

“Studies have shown that spinal cord lesions are associated with a greater than 50% chance of converting to MS,” said Dr. Hosseiny, who was the lead author of a review article on RIS. “Identifying such imaging findings can help identify patients who may benefit from disease-modifying medications.”

Dr. Lebrun-Frenay reports no potential conflicts of interest. Dr. Okuda has financial relationships with Alexion, Biogen, Celgene, EMD Serono, Genzyme, TG Therapeutics, and VielaBio. Dr. Hosseiny reports no potential conflicts of interest.

Among women with early-stage, high-risk breast cancer, strong adherence to prevention recommendations was linked with a significantly reduced risk of breast cancer recurrence and mortality in a new study.

Following such recommendations surrounding smoking, physical activity (PA), eating fruits and vegetables and reducing or eliminating sugar-sweetened beverages seemed to be the most beneficial, wrote the authors of the paper published online in JAMA Network Open.

Rikki A. Cannioto, PhD, EdD, with the department of cancer prevention & control, Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., led the prospective cohort study of 1,340 patients.

The American Institute for Cancer Research and American Cancer Society regularly recommend and publish lifestyle modifications for cancer prevention. To conduct this study Dr. Cannioto and colleagues developed an aggregate lifestyle scoring index to investigate whether those recommendations have an effect on high-risk breast cancer survival.

Highest adherence vs. lowest cut death risk by more than half

The researchers found patients with highest vs. lowest lifestyle index scores saw a 37% reduction in cancer recurrence (hazard ratio, 0.63; 95% confidence interval, 0.48-0.82) and a 58% reduction in mortality (HR, 0.42; 95% CI, 0.30-0.59).

“As a person who has based her career on the belief that our modifiable lifestyle behaviors are associated with cancer survival, I was actually surprised about how strong these associations were, especially for breast cancer recurrence,” Dr. Cannioto said in an interview,

The author also expressed surprise about the associations that were seen “in patients diagnosed with triple-negative breast cancer and HER2-positive breast cancer, which are the two subtypes traditionally more aggressive and more difficult to treat.”

Most patients in the study were diagnosed with hormone receptor–positive breast cancer (873 [65.3%]); completed some education beyond high school (954 [71.2%]); were postmenopausal (696 [52.5%]); and self-identified as non-Hispanic White (1,118 [83.7%]).

Patients were drawn from the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) study, a prospective, observational cohort study ancillary to a multicenter phase 3 trial led by the Southwest Oncology Group (SWOG). The DELCaP study was designed to examine lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment.

Never smoking, physical activity had strongest links

Never smoking and meeting or exceeding PA guidelines had the strongest and most consistent associations with outcomes; each factor was linked with a 44%-45% reduced risk of mortality and a 35% reduced risk of recurrence.

Strongest adherence to the alcohol and body mass index (BMI) recommendations were not significantly associated with improved outcomes.

Partial and full adherence to red and processed meat recommendations were associated with significant reductions in mortality, but not recurrence.

The authors note that, while medications are the foundation for breast cancer treatment, lifestyle interventions could be a safe and inexpensive additional strategy for delaying and preventing recurrence and death.

“Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies,” they write.

Dr. Cannioto says the guidelines around physical activity advise 150 minutes or more of moderate to vigorous intensity a week. But she noted that this research shows that any physical activity can lead to longer survival.

“The greatest benefits from physical activity occur from moving from a sedentary lifestyle to beginning to be active,” she said.

Dr. Cannioto acknowledged the homogeneity of the study population as a limitation and recommended the associations next be tested in a more racially and ethnically diverse population of breast cancer patients.

This work was supported by the National Cancer Institute, the Breast Cancer Research Foundation, and Amgen.

The authors report receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and receiving personal fees, grants, or serving on the boards or independent monitoring committees of many pharmaceutical companies. A full list of disclosures is available with the paper.

Among women with early-stage, high-risk breast cancer, strong adherence to prevention recommendations was linked with a significantly reduced risk of breast cancer recurrence and mortality in a new study.

Following such recommendations surrounding smoking, physical activity (PA), eating fruits and vegetables and reducing or eliminating sugar-sweetened beverages seemed to be the most beneficial, wrote the authors of the paper published online in JAMA Network Open.

Rikki A. Cannioto, PhD, EdD, with the department of cancer prevention & control, Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., led the prospective cohort study of 1,340 patients.

The American Institute for Cancer Research and American Cancer Society regularly recommend and publish lifestyle modifications for cancer prevention. To conduct this study Dr. Cannioto and colleagues developed an aggregate lifestyle scoring index to investigate whether those recommendations have an effect on high-risk breast cancer survival.

Highest adherence vs. lowest cut death risk by more than half

The researchers found patients with highest vs. lowest lifestyle index scores saw a 37% reduction in cancer recurrence (hazard ratio, 0.63; 95% confidence interval, 0.48-0.82) and a 58% reduction in mortality (HR, 0.42; 95% CI, 0.30-0.59).

“As a person who has based her career on the belief that our modifiable lifestyle behaviors are associated with cancer survival, I was actually surprised about how strong these associations were, especially for breast cancer recurrence,” Dr. Cannioto said in an interview,

The author also expressed surprise about the associations that were seen “in patients diagnosed with triple-negative breast cancer and HER2-positive breast cancer, which are the two subtypes traditionally more aggressive and more difficult to treat.”

Most patients in the study were diagnosed with hormone receptor–positive breast cancer (873 [65.3%]); completed some education beyond high school (954 [71.2%]); were postmenopausal (696 [52.5%]); and self-identified as non-Hispanic White (1,118 [83.7%]).

Patients were drawn from the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) study, a prospective, observational cohort study ancillary to a multicenter phase 3 trial led by the Southwest Oncology Group (SWOG). The DELCaP study was designed to examine lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment.

Never smoking, physical activity had strongest links

Never smoking and meeting or exceeding PA guidelines had the strongest and most consistent associations with outcomes; each factor was linked with a 44%-45% reduced risk of mortality and a 35% reduced risk of recurrence.

Strongest adherence to the alcohol and body mass index (BMI) recommendations were not significantly associated with improved outcomes.

Partial and full adherence to red and processed meat recommendations were associated with significant reductions in mortality, but not recurrence.

The authors note that, while medications are the foundation for breast cancer treatment, lifestyle interventions could be a safe and inexpensive additional strategy for delaying and preventing recurrence and death.

“Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies,” they write.

Dr. Cannioto says the guidelines around physical activity advise 150 minutes or more of moderate to vigorous intensity a week. But she noted that this research shows that any physical activity can lead to longer survival.

“The greatest benefits from physical activity occur from moving from a sedentary lifestyle to beginning to be active,” she said.

Dr. Cannioto acknowledged the homogeneity of the study population as a limitation and recommended the associations next be tested in a more racially and ethnically diverse population of breast cancer patients.

This work was supported by the National Cancer Institute, the Breast Cancer Research Foundation, and Amgen.

The authors report receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and receiving personal fees, grants, or serving on the boards or independent monitoring committees of many pharmaceutical companies. A full list of disclosures is available with the paper.

Among women with early-stage, high-risk breast cancer, strong adherence to prevention recommendations was linked with a significantly reduced risk of breast cancer recurrence and mortality in a new study.

Following such recommendations surrounding smoking, physical activity (PA), eating fruits and vegetables and reducing or eliminating sugar-sweetened beverages seemed to be the most beneficial, wrote the authors of the paper published online in JAMA Network Open.

Rikki A. Cannioto, PhD, EdD, with the department of cancer prevention & control, Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., led the prospective cohort study of 1,340 patients.

The American Institute for Cancer Research and American Cancer Society regularly recommend and publish lifestyle modifications for cancer prevention. To conduct this study Dr. Cannioto and colleagues developed an aggregate lifestyle scoring index to investigate whether those recommendations have an effect on high-risk breast cancer survival.

Highest adherence vs. lowest cut death risk by more than half

The researchers found patients with highest vs. lowest lifestyle index scores saw a 37% reduction in cancer recurrence (hazard ratio, 0.63; 95% confidence interval, 0.48-0.82) and a 58% reduction in mortality (HR, 0.42; 95% CI, 0.30-0.59).

“As a person who has based her career on the belief that our modifiable lifestyle behaviors are associated with cancer survival, I was actually surprised about how strong these associations were, especially for breast cancer recurrence,” Dr. Cannioto said in an interview,

The author also expressed surprise about the associations that were seen “in patients diagnosed with triple-negative breast cancer and HER2-positive breast cancer, which are the two subtypes traditionally more aggressive and more difficult to treat.”

Most patients in the study were diagnosed with hormone receptor–positive breast cancer (873 [65.3%]); completed some education beyond high school (954 [71.2%]); were postmenopausal (696 [52.5%]); and self-identified as non-Hispanic White (1,118 [83.7%]).

Patients were drawn from the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) study, a prospective, observational cohort study ancillary to a multicenter phase 3 trial led by the Southwest Oncology Group (SWOG). The DELCaP study was designed to examine lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment.

Never smoking, physical activity had strongest links

Never smoking and meeting or exceeding PA guidelines had the strongest and most consistent associations with outcomes; each factor was linked with a 44%-45% reduced risk of mortality and a 35% reduced risk of recurrence.

Strongest adherence to the alcohol and body mass index (BMI) recommendations were not significantly associated with improved outcomes.

Partial and full adherence to red and processed meat recommendations were associated with significant reductions in mortality, but not recurrence.

The authors note that, while medications are the foundation for breast cancer treatment, lifestyle interventions could be a safe and inexpensive additional strategy for delaying and preventing recurrence and death.

“Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies,” they write.

Dr. Cannioto says the guidelines around physical activity advise 150 minutes or more of moderate to vigorous intensity a week. But she noted that this research shows that any physical activity can lead to longer survival.

“The greatest benefits from physical activity occur from moving from a sedentary lifestyle to beginning to be active,” she said.

Dr. Cannioto acknowledged the homogeneity of the study population as a limitation and recommended the associations next be tested in a more racially and ethnically diverse population of breast cancer patients.

This work was supported by the National Cancer Institute, the Breast Cancer Research Foundation, and Amgen.

The authors report receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and receiving personal fees, grants, or serving on the boards or independent monitoring committees of many pharmaceutical companies. A full list of disclosures is available with the paper.